Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067) (SATISFACTION)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: July 30, 2008
Last updated: January 28, 2015
Last verified: January 2015

The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegPen. The goal of this study is to determine the satisfaction grade with this novel device.

Condition Intervention
Hepatitis C, Chronic
Biological: Peginterferon alfa-2b (SCH 54031)
Drug: Ribavirin (SCH 18908)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months [ Time Frame: The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment. ] [ Designated as safety issue: No ]
    Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).

Enrollment: 1995
Study Start Date: October 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with chronic hepatitis C
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b will be administered according to the products' labeling.
Other Names:
  • PegIntron
  • PegPen
Drug: Ribavirin (SCH 18908)
Ribavirin will be administered according to the products' labeling.
Other Name: Rebetol

Detailed Description:

Enrollment of patients will occur in a sequential order of treatment initiation.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol at sites in France.


Inclusion Criteria:

  • Adult patients with hepatitis C

Exclusion Criteria:

  • According to the products' labeling.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00727259

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Clinical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00727259     History of Changes
Other Study ID Numbers: P04067
Study First Received: July 30, 2008
Results First Received: June 18, 2009
Last Updated: January 28, 2015
Health Authority: France: Not Applicable

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2b
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 27, 2015